Efficacy of Combined Fractional Er:Glass and Thulium Lasers Versus Microneedling for Atrophic Acne Scars

NCT07151599 | Recruiting DMC

• 1 other identifier: ErGlass_MedicinaBiofotonica
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two treatments for acne scars on the face. The study will test whether fractional lasers (Erbium:Glass and Thulium) lead to better improvement in acne scars than microneedling.

Conditions

Acne Scars

Keywords

Fractionated Erbium Glass Laser; Fractionated Thulium Laser; Microneedling; Percutaneous Induction of Collagen; Acne Scars

Outcome Measures

Primary Outcomes (3)

• ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)

  The ECCA is a validated scale that quantifies acne scars through both qualitative and quantitative components. Scar type is weighted by a numerical factor (15-30 for atrophic scars and elastosis; 40-50 for hypertrophic/keloid scars) and multiplied by the number of lesions, graded on a 4-point scale: 0 = none; 1 = \<5 scars; 2 = 5-20 scars; 3 = \>20 scars. The global score ranges from 0 to 540, with higher scores indicating greater severity. In this study, participants with hypertrophic or keloid scars will be excluded; therefore, only atrophic scar subtypes will be scored (subcategory 1).

  Assessments will be performed by blinded evaluators using standardized photographs at baseline.

• ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)

  The ECCA is a validated scale that quantifies acne scars through both qualitative and quantitative components. Scar type is weighted by a numerical factor (15-30 for atrophic scars and elastosis; 40-50 for hypertrophic/keloid scars) and multiplied by the number of lesions, graded on a 4-point scale: 0 = none; 1 = \<5 scars; 2 = 5-20 scars; 3 = \>20 scars. The global score ranges from 0 to 540, with higher scores indicating greater severity. In this study, participants with hypertrophic or keloid scars will be excluded; therefore, only atrophic scar subtypes will be scored (subcategory 1).

  Assessments will be performed by blinded evaluators using standardized photographs at 30 days after the last session.

• ECCA grading scale (échelle d'évaluation clinique des cicatrices d'acné)

  The ECCA is a validated scale that quantifies acne scars through both qualitative and quantitative components. Scar type is weighted by a numerical factor (15-30 for atrophic scars and elastosis; 40-50 for hypertrophic/keloid scars) and multiplied by the number of lesions, graded on a 4-point scale: 0 = none; 1 = \<5 scars; 2 = 5-20 scars; 3 = \>20 scars. The global score ranges from 0 to 540, with higher scores indicating greater severity. In this study, participants with hypertrophic or keloid scars will be excluded; therefore, only atrophic scar subtypes will be scored (subcategory 1).

  Assessments will be performed by blinded evaluators using standardized photographs at 16 weeks after the last session.

Secondary Outcomes (17)

• Global Aesthetic Improvement Scale (GAIS)

  From baseline to 30 days after the end of the treatment

• Global Aesthetic Improvement Scale (GAIS)

  From baseline to 16 weeks after the end of the treatment

• Goodman & Baron Acne Scar Scale

  Baseline

• Goodman & Baron Acne Scar Scale

  30 days after the end of the treatment

• Goodman & Baron Acne Scar Scale

  16 weeks after the end of the treatment

Study Arms (2)

Microneedling

ACTIVE COMPARATOR

Microneedling performed with an electronic pen and sterile disposable cartridge of 12 needles at 2mm depth

Device: Microneedling

Fractionated Er:Glass and Thulium Lasers

EXPERIMENTAL

Fractional Erbium:Glass laser is applied first, focused on scarred areas, followed immediately by fractional Thulium 1927 nm over the full face.

Device: Fractionated Er:Glass Laser combined to Fractionated Thulium Laser

Interventions

Microneedling DEVICE

Microneedling performed with an electronic pen and sterile disposable cartridge with 12 needles and 2mm depth, three treatment sessions at four-week intervals.

Microneedling

Fractionated Er:Glass Laser combined to Fractionated Thulium Laser DEVICE

Fractional Erbium:Glass laser will be applied first, focused on scarred areas (50 mJ, 15 ms e 100 PPA) , followed immediately by fractional Thulium 1927 nm over the full face (10 mJ, 1 ms e 100 PPA), three treatment sessions at four-week intervals.

Fractionated Er:Glass and Thulium Lasers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: cisgender women and cisgender men
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Fitzpatrick skin phototypes I to VI
• Presence of atrophic acne scars on the face

You may not qualify if:

• Decompensated systemic diseases
• Any active infection (e.g., viral such as herpes, bacterial, or fungal)
• Pregnant or breastfeeding women
• Presence of hypertrophic or keloid scars
• Current use of anticoagulant or antiplatelet medications
• History of hemophilia or coagulation disorders
• Current use of anti-inflammatory drugs or corticosteroids
• Use of retinoids, including isotretinoin, within the past 6 months
• Exposure to sunlight within the past 15 days
• Undergoing any aesthetic facial treatment or having undergone scar treatments in the facial region within 180 days prior to study initiation

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Espaço Conceito Medical San

São Paulo, Brazil

RECRUITING

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Christiane Pavani, PhD

  University of Nove de Julho

  STUDY CHAIR

• Luciana Khachikian, Master Student

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Khachikian, Master student

CONTACT

+5511989969924; lucianacamargo@uni9.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assesor evaluation of the outcomes will be performed in anonymous pictures. The participant reported outcomes will not be blinded, since participant will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Randomized Controlled Trial Comparing Combined Fractional Erbium:Glass and Thulium Lasers Versus Microneedling for the Treatment of Atrophic Acne Scars

Model Details: Participants are assigned to Microneedling or Combination of Thulium and Erbium Glass Fractionated Laser in parallel.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: October 16, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The IPD will be available after the publication of the results, for 10 years.
• Access Criteria: The IPD will be available as a excel file.

Locations

BR (1)